FDA Publishes New Set of Real-World Evidence Examples
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas.
Tag Archives: RWE
The Agile MedTech Lifecycle: Rethinking Regulatory Adoption in a Time of Global Disruption
The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.
CDER establishes new Center for Real-World Evidence Innovation
According to CDER Director Patrizia Cavazzoni, CDER’s new Center for Real-World Evidence Innovation represents a major step forward in efforts to unlock the full potential of RWD to inform clinical and regulatory decisions.
APF 2024: Shaping the Future of Real-World Evidence and AI in Healthcare
The MDIC Annual Public Forum 2024 kicked off this week with experts from the National Evaluation System for health Technology (NEST), the Centers for Medicare and Medicaid Services (CMS), and the FDA. Topics included the future of real-world evidence (RWE) and the integration of AI into the healthcare ecosystem and how can we leverage emerging technologies to bring innovative and safer solutions to patients.
Everybody is looking for Evidence — Bridging Regulatory & Reimbursement: Strategies for Success
As medical technology products and services move through the development pipeline, they face the challenge of both showing safety and efficacy for regulatory approval and articulating the value of the diagnostic, treatment or monitoring technology to obtain reimbursement from payers. A 2024 MedExec Women Conference panel highlighted strategies to bridge the evidence needs for regulatory approval and reimbursement to more efficiently bring products to market.
Reliable Active Surveillance: RWE for MedTech
As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.
AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research
Genomics data scientist Harsha Rajasimha, Ph.D., Founder and Executive Chairman of IndoUSrare, highlights the risks of developing AI/ML algorithms based on biased data, as well as efforts underway to improve global collaboration on the collection and sharing of health data that may help us realize the potential of AI in diagnoses and treatment of rare diseases.